Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
NCT Number: NCT06237673
CAD-Man Extend is the long-term follow-up (clinical, laboratory, and computed tomography (CT) imaging) of a single-center, randomized, controlled CAD-Man trial comparing a CT-first strategy with a direct- invasive coronary angiography (ICA) diagnostic and management strategy, in 329 patients clinically referred for ICA with atypical angina or chest pain.
Overall goal:
The extension of CAD-Man follow-up (clinical, laboratory, and CT imaging) to approximately 10 years will provide the opportunity to compare plaque burden with CT-guided management versus direct-ICA at long-term and other endpoints.
Looking for future studies?
Notify Me30 year and older
All sexes
Interventional
Not applicable
Berlin, 10117, Germany
The CAD-Man (Coronary Artery Disease Management with Multislice Computed Tomography and Magnetic Resonance Imaging in Patients with Atypical Angina Pectoris) trial evaluated whether computed tomography (CT) or invasive coronary angiography (ICA) should be performed in patients clinically referred for coronary angiography with an intermediate probability of coronary artery disease. Patients with suspected CAD were randomized 1:1 ratio to CT, followed by ICA if positive for obstructive CAD, or to direct ICA. In both tests, obstructive CAD was defined as at least a 50% diameter stenosis in the left main coronary artery or at least a 70% diameter stenosis in other coronary arteries. Investigators and participants were blinded to randomization sequence but could not be blinded to the assigned group because of the apparent differences between CT and ICA. Independent investigators, who were blinded to the randomization group and were not part of the study team, anonymously assessed outcomes. Results on the comparative effectiveness of CT and ICA in preventing the primary outcome of major procedural complications within 48 hours of the last procedure and major adverse events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) were published for a median follow-up of 3.3 years.
The primary results and additional subgroup analyses of the CAD-Man trial led to three new hypotheses that will be evaluated in the CAD-Man Extend study.
Whether CT-guided management of patients with atypical angina results in a reduction in coronary plaque burden (as determined by repeat CT scan) compared with direct-ICA management until 10 years.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
for additional CT scan:
CT-directed clinical management strategy
Standard clinical management directed by conventional invasive coronary angiography (ICA).
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Cardiovascular events (unstable angina pectoris, re-revascularization, and first revascularization at least 2 months after randomization)
Time frame: at 10 years
To compare cost-effectiveness in both groups using the quality-adjusted life year data, and cost data derived from the trial.
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Stenosis (no stenosis, <20%, 20 to 50%, >50%)
Time frame: at 10 years
(calcified, non-calcified (fibrous, fibrofatty, lipid-rich), partially calcified)
Time frame: at 10 years
(HRP; positive remodelling (PR), napkin ring sign, spotty calcification, low attenuation (LAP)
Time frame: at 10 years
Age (< 65, 65-75, > 75)
Body Mass Index (BMI) (< 25, 25-30, > 30) Gender (male versus female) Diabetes (yes/no)
Time frame: at 10 years
Age (< 65, 65-75, > 75)
Body Mass Index (BMI) (< 25, 25-30, > 30) Gender (male versus female) Diabetes (yes/no)
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Time frame: at 10 years
Charite University, Berlin, Germany
Other
A Randomized, Controlled Trial in Patients With Suspected Coronary Artery Disease Based on Acute or Chronic Atypical Angina Pectoris - EXTEND
Acronym: CAD-Man-EXTEND
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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